Home / Recalls / Gyrus Medical, Inc / Z-0100-2015

Z-0100-2015 Class II Terminated

Recalled by Gyrus Medical, Inc — Osseo, MN

Recall Details

Product Type: Devices
Report Date: October 29, 2014
Initiation Date: August 27, 2014
Termination Date: September 15, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5520 US, 40 OUS

Product Description

GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

Reason for Recall

Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.

Distribution Pattern

Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.

Code Information

All product manufactured before July 28, 2014.